Pronase Granules in Gastric Cleaning

Phase 2

• Conditions: Gastric Disease; Capsule Endoscopy
• Interventions: Drug: Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8

• Registration Number: NCT05249933
• Lead Sponsor: Changhai Hospital

Brief Summary

Magnetically controlled capsule endoscopy (MCE) is now widely used all over the world. However, the standard gastric preparation method by dimethicone we used clinically still has mucus at the bottom of the stomach. In this study, we aimed to determine whether pronase granules is helpful to improve the cleanliness of gastric mucosa in MCE.

Detailed Description

As a non-invasive and well-tolerated gastrointestinal examination method, magnetically controlled capsule endoscopy (MCE) is being increasingly used in different populations in recent years. Gastric preparation is extremely important for the completion rate (CR), image quality, and diagnostic efficiency because of the plica of gastric mucosa and the autonomous movement of the capsule in the gastrointestinal tract. After a series of explorations including air-producing powder, defoamer, protease preparation, patients are asked to drink about 800 ml-1000 ml water in a short time for standard gastric filling. However, the existing problems of gastric preparation such as abdominal distension, insufficient gastric filling, and long gastric retention time deserve attention. Different from the results of Zhu et al. (DLD, 2017), the current clinical experience shows that the addition of pronase granules in gastric preparation can often reduce the mucus in the stomach. But the standardized use of pronase granules remains to be further explored.

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-24
• Study First Submitted: 2022-02-09
• Primary Completion: 2022-02-20
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. Age ≥ 18 years old.
2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese People's Liberation Army General Hospital after January 2020.
3. Able to provide informed consent.

Exclusion Criteria

1. dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation;
2. congestive heart failure, renal insufficiency, use of anticoagulant medication,
3. implanted metallic devices such as pacemakers, defibrillators, artificial heart valves or joint prostheses (although the low magnetic field used technically should not interfere with such devices);
4. pregnancy;
5. currently participating in another clinical study.
6. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
7. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
8. Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
9. The patient's basic information in the database is incomplete#
10. Patient fail to be followed up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8	All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of two liters of polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at the hospital in the morning after an overnight fast (\>8hours). Then they would be randomly assigned to the control group or pronase group randomly. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg dimethicone. And 25 minutes before swallowing the capsule, the patient was asked to take 200ml warm water. There is still have 800-1000ml water for gastric filling 10 minutes before swallowing the capsule.
Pronase group	Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8	All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of two liters of polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at the hospital in the morning after an overnight fast (\>8hours). Then they would be randomly assigned to the control group or pronase group randomly. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg dimethicone. And 25 minutes before swallowing the capsule, the patient was asked to take 20000 IU pronase Granules Combined with 1 g NaHCO3 dissolved in 200ml warm water to maintain the intragastric pH at 6 - 8. There is still have 800-1000ml water for gastric filling 10 minutes before swallowing the capsule.

Primary Outcome Measures

Name	Time	Method
Gastric Cleanliness Score (GCS)	2 weeks	Six primary anatomical landmarks of the stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but do not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1). GCS was the total scores of all six landmarks, ranging from 6 (completely unprepared) to 24 (perfect). GCS of≥18 was regarded as acceptable.

Secondary Outcome Measures

Name	Time	Method
Fullness score	2 weeks	Fullness is the subjective feeling of patients assessed with visual analogue scale (VAS). VAS typically take the form of a straight line with two extreme states anchored at either end. In this study, it is a 100mm VAS with a question"How full do you feel?"anchored with "not at all full"at the left side and "as full as I have ever felt" at the right side. Patients will be asked to mark their feelings on the line. The distance (mm) between the far left and the marked point is the score of fullness. 0 represents no perception at all, 10 indicates pain and needs to be stopped immediately.
Esophageal transit time (ETT)	2 weeks	The time between the first image of esophagus and the first image of stomach.
Small bowel transit time (SBTT)	2 weeks	The time between the last image of stomach and the image of ileocecal valve.
Detection rate of lesions	2 weeks	The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
Gastric Examination Time (GET)	2 weeks	The time taken for the gastric examination to the endoscopist's satisfaction.
Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel	2 weeks	Visualization of the small bowel was determined by the percentage of time during which the small-bowel view was clear, defined as not obscured more than 50% of the screen view. The clear-viewing percentage of the total small bowel transit time assessed by a 4-point scale :0, less than 25%; 1, 25% to 49%; 2, 50% to 75%; and 3, greater than 75%.
Completion Rate (CR)	2 weeks	The completion of stomach was defined as the observation of cardia, fundus, body, angulus, antrum and pylorus and the completion of small bowel examination was defined as the ileocecal valve was photographed.The completion rate in each group was defined as the percentage of patients with a complete examination out of the total number of patients examined.
Gastric transit time (GTT)	2 weeks	The time between the first image of stomach and the last image of stomach.
Adverse events occurence rate	2 weeks	The safety were evaluated at two week after procedure for any adverse events such as infection, pain, nausea, vomiting and capsule impaction or retention.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China